Effect of PEEP and Trendelenburg on Ultrasound Size of Internal Jugular and Subclavian Veins

NCT02569424 | Completed

• 2 other identifiers: CHU-02462015-A00606-43
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

There is no recommendation for the management of the positive end-expiratory pressure (PEEP) during setting of a central venous catheter (CVC) in a ventilated patient. Several non-randomized studies have investigated the cross-sectional area (AST) ultrasound minor axis for different pressure levels by evaluating a single vessel every time or by not displaying the right or left side in the evaluation. Another study showed that there could be unpredictable size differences between the 2 subclavian veins. In ventilated patient, the PEEP, which is intrathoracic, will result in a decrease of venous return and thus possibly a superior vena cava dilation, located outside the pleura, depending on their capacitance. Different pressure levels showed an increase of AST with the increase of intra-thoracic pressure on certain veins, in a heterogeneous and not randomized manner. The primary purpose of the study is to measure the effect of PEEP (0, 5, 10 or 15 cm H2O) and the patient's position (supine or Trendelenburg strict -15-20 °) on the cross-sectional area of the jugular and subclavian veins.

Conditions

Ventilated Patient in Intensive Care; Management of the Expiratory End-expiratory Pressure (PEEP) and Body Position

Keywords

PEEP level; Trendelenburg position; cross-sectional area of the jugular and subclavian veins; central venous catheter

Outcome Measures

Primary Outcomes (1)

• The cross-sectional area of the jugular veins ( in cm2)

  The cross-sectional area of the jugular veins ( in cm2) at the end of the intervention

  at baseline

Secondary Outcomes (5)

• The cross-sectional area of the subclavian veins ( in cm2)

  at baseline

• The antero-posterior diameter of the jugular veins (in mm)

  at baseline

• The antero-posterior diameter of the subclavian veins (in mm)

  at baseline

• The distance between posterior and pleural lining of the jugular veins (in mm)

  at baseline

• The distance between posterior and pleural lining of the subclavian veins (in mm)

  at baseline

Study Arms (1)

ventilated patients

EXPERIMENTAL

Patient's position (Supine or Trendelenburg strict -20°)

Behavioral: Patient's position

Interventions

Patient's position BEHAVIORAL

Supine or Trendelenburg strict -20°)

ventilated patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any patient ventilated in intensive care is eligible.
• Age ≥ 18 years
• Patient with stable hemodynamic status and Mean Blood Pressure (\< 65 mmHg)
• Patient with registered social security number

You may not qualify if:

• presence of a central line for more than 48 hours.
• Anechoic patient (checked during echography screening)
• History of cervical spine surgery.
• IntraCranial HyperTension
• patient in shock with hemodynamic instability and not stabilized
• patient treated by noradrenaline \> 1 µg/kg/min
• patient or relative's refusal
• protected patients ≥ 18 years, minors, pregnant women

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Study Officials

• Sébastien PERBET

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2015
• First Posted: October 6, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: December 5, 2016

Record last verified: 2016-12

Locations

FR (1)